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New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering (NARA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshihiko Saito, Nara Medical University
ClinicalTrials.gov Identifier:
NCT01609959
First received: May 30, 2012
Last updated: October 28, 2013
Last verified: October 2013

May 30, 2012
October 28, 2013
June 2012
September 2013   (final data collection date for primary outcome measure)
Change in Office Blood Pressure [ Time Frame: Baseline and every 2 weeks (up to 12 weeks) ] [ Designated as safety issue: No ]
Change in blood pressure measured at a clinic
Change in Office Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in blood pressure measured at a clinic
Complete list of historical versions of study NCT01609959 on ClinicalTrials.gov Archive Site
  • Change in Home Blood Pressure [ Time Frame: Baseline and every 2 weeks (up to 12 weeks) ] [ Designated as safety issue: No ]

    Change in blood pressure measured at home

    Blood pressure is measured twice daily in the morning fasting before taking any drugs.

  • Change in Renal Function [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Changes in levels of serum creatinine and proteinuria
  • Change in Fasting Triglyceride [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in Glycemic Control [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)
  • Change in Plasma Aldosterone Concentration [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Only in patients with secondary hypertension
  • Change in Home Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in blood pressure measured at home
  • Change in Renal Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in levels of serum creatinine and proteinuria
  • Change in Fasting Triglyceride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Glycemic Control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)
  • Change in Plasma Aldosterone Concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Only in patients with secondary hypertension
Not Provided
Not Provided
 
New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering
Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension

The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.

Hypertension plays a major role in the development of cardiovascular disease. Several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor.

A new angiotensin II receptor blocker (ARB), azilsartan, is the first drug which is superior to other ARBs in blood pressure lowering in phase III clinical trials in Japan. We try to evaluate effect of azilsartan on blood pressure lowering in Japanese patients with hypertension who have already taken normal-dose ARBs, and to compare it with that of valsartan.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Azilsartan
    Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks
  • Drug: Valsartan
    Valsartan 160 mg per day
  • Active Comparator: Azilsartan group
    Intervention: Drug: Azilsartan
  • Active Comparator: Valsartan group
    Intervention: Drug: Valsartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan
  • Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day.

Exclusion Criteria:

  • Hypersensitivity for azilsartan and valsartan
  • Pregnant female
  • History of azilsartan use within 3 months
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01609959
12-Ken-001
Yes
Yoshihiko Saito, Nara Medical University
Nara Medical University
Not Provided
Principal Investigator: Yoshihiko Saito, MD, PhD First Department of Internal Medicine, Nara Medical University
Nara Medical University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP